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    Clinical Trial Results:
    A phase III trial evaluating the efficacy and safety of the house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet in children and adolescents (5-17 years) with HDM allergic asthma

    Summary
    EudraCT number
    		 2016-004363-39
    Trial protocol
    		 DE   ES   HU   BG   DK   FR   PL   GB  
    Global end of trial date
    10 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Mar 2023
    First version publication date
    12 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MT-11
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03654976
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ALK-Abelló A/S
    Sponsor organisation address
    Bøge Allé 6-8, Hørsholm, Denmark, 2970
    Public contact
    Global pharmacovigilance and Clinical Development, ALK-Abelló A/S, 0045 45747576, clinicaltrials@alk.net
    Scientific contact
    Global pharmacovigilance and Clinical Development, ALK-Abelló A/S, 0045 45747576, clinicaltrials@alk.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001258-PIP01-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to demonstrate efficacy of the HDM SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with HDM allergic asthma based on clinically relevant asthma exacerbations after at least 4 months of treatment. A clinically relevant asthma exacerbation was defined as at least 1 of the following criteria: a) Doubling of ICS dose compared to background treatment, b) Systemic corticosteroids for treatment of asthma symptoms for at least 3 days, c) Emergency room visit due to asthma, requiring systemic corticosteroids or d) Hospitalisation for more than 12 hours due to asthma, requiring treatment with systemic corticosteroids
    Protection of trial subjects
    Safety surveillance. Access to rescue medication.
    Background therapy
    		 Background treatment: The asthma background treatment consisted of low dose inhaled corticosteroid (ICS) plus long-acting β2-agonist (LABA) or medium/high dose ICS with/without LABA. In addition, the subject could continue treatment with leukotriene receptor antagonists if this was part of the subject's background treatment when entering the trial. The subject had to stay on the same background treatment and dose throughout the trial as they were on when they entered the trial. Rescue medication: Subjects were provided with rescue medication to treat asthma symptoms (SABA), asthma exacerbations (ICS and/or prednisolone/prednisone), rhinoconjunctivitis symptoms (antihistamine/intranasal corticosteroid) and, in countries where required, to treat severe allergic reactions (adrenaline auto-injector).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 38
    Country: Number of subjects enrolled
    United States: 26
    Country: Number of subjects enrolled
    Poland: 291
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Bulgaria: 65
    Country: Number of subjects enrolled
    France: 25
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Hungary: 37
    Worldwide total number of subjects
    533
    EEA total number of subjects
    465
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    316
    Adolescents (12-17 years)
    217
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 64 trial sites in Bulgaria, France, Germany, Hungary, Poland, Spain, Russia, United Kingdom and USA. First subject first visit: 22-February-2018 Last subject last visit: 31-May-2022

    Pre-assignment
    Screening details
    		 Main selection criteria: - 5-17 years at randomisation - Clinical history of HDM allergic asthma of at least 1 year - At least 3 clin. relevant asthma exacerbations in past 2 years, 2 clin. relevant asthma exacerbations in past year or 1 severe asthma exacerbation in past year - Positive SPT and IgE against D. pteronyssinus and/or D. farinae

    Period 1
    Period 1 title
    Overall trial (IMP start and completion) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo SLIT-tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral lyophilisate
    Routes of administration
    Sublingual use
    Dosage and administration details
    The subject was instructed to preferably take the tablet in the morning and that food and beverages should not be taken for the following 5 minutes. When the first dose was administered, the subject was under medical supervision for the subsequent ≥ 30 minutes.

    Arm title
    		 12 SQ-HDM
    Arm description
    		 HDM SLIT-tablet (12 SQ-HDM)
    Arm type
    		 Experimental

    Investigational medicinal product name
    HDM SLIT-tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral lyophilisate
    Routes of administration
    Sublingual use
    Dosage and administration details
    The subject was instructed to preferably take the tablet in the morning and that food and beverages should not be taken for the following 5 minutes. When the first dose was administered, the subject was under medical supervision for the subsequent ≥ 30 minutes.

    Number of subjects in period 1
    		Placebo 12 SQ-HDM
    Started
    263
    270
    Completed
    242
    239
    Not completed
    21
    31
         Physician decision
    1
    1
         Consent withdrawn by subject
    11
    11
         Reason stated as "other" in CRF
    6
    10
         Adverse event, non-fatal
    1
    6
         3 severe asthma exacerb. within 12 consec. mths.
    1
    1
         Lost to follow-up
    -
    2
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    12 SQ-HDM
    Reporting group description
    		 HDM SLIT-tablet (12 SQ-HDM)

    Reporting group values
    		 Placebo 12 SQ-HDM Total
    Number of subjects
    		 263 270 533
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 154 162 316
        Adolescents (12-17 years)
    		 109 108 217
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 94 88 182
        Male
    		 169 182 351
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set, defined as all randomised subjects who received at least 1 dose of IMP. Subjects were included as randomised, i.e., according to their randomised assignment of treatment. 9 randomised subjects were excluded from the full analysis set

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set, defined as all randomised subjects who received at least 1 dose of IMP. Subjects were included as treated, i.e., according to the treatment they actually received.

    Subject analysis sets values
    		 Full analysis set Safety analysis set
    Number of subjects
    524
    533
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    315
    316
        Adolescents (12-17 years)
    209
    217
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    178
    182
        Male
    346
    351

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    12 SQ-HDM
    Reporting group description
    		 HDM SLIT-tablet (12 SQ-HDM)

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set, defined as all randomised subjects who received at least 1 dose of IMP. Subjects were included as randomised, i.e., according to their randomised assignment of treatment. 9 randomised subjects were excluded from the full analysis set

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set, defined as all randomised subjects who received at least 1 dose of IMP. Subjects were included as treated, i.e., according to the treatment they actually received.

    Primary: Annualised rate of clinically relevant asthma exacerbations

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    End point title
    		 Annualised rate of clinically relevant asthma exacerbations
    End point description
    The primary endpoint of the trial was the annualised rate of clinically relevant asthma exacerbations calculated as the number of exacerbations per year per subject during the efficacy evaluation period (starting 4-10 months after treatment initiation and lasting up to 24-30 months of treatment). A clinically relevant asthma exacerbation had to be medically confirmed and was defined as asthma worsening leading to at least 1 of the following criteria: • Doubling of ICS dose compared to background treatment • Systemic corticosteroids for treatment of asthma symptoms for at least 3 days • Emergency room visit due to asthma, requiring systemic corticosteroids • Hospitalisation for more than 12 hours due to asthma, requiring treatment with systemic corticosteroids
    End point type
    Primary
    End point timeframe
    The efficacy assessment period for the primary endpoint started 01-sep (4-10 months after treatment initiation) and lasted until the end of trial or discontinuation of treatment.
    End point values
    		 Placebo 12 SQ-HDM
    Number of subjects analysed
    257 [1]
    252 [2]
    Units: Per year per subject
        number (not applicable)
    0.21
    0.18
    Notes
    [1] - Subjects from the full analysis set with observations in the efficacy assessment period
    [2] - Subjects from the full analysis set with observations in the efficacy assessment period
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    The number of clinically relevant asthma exacerbations was analysed using a negative binomial regression model with a log-link function and the logarithm of the time in years in the efficacy period as offset. The model included treatment, age group (<12 years, >=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.
    Comparison groups
    Placebo v 12 SQ-HDM
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5412
    Method
    		 Negative binomial regression
    Parameter type
    		 Rate ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.31

    Secondary: Proportion of days with nocturnal awakenings due to asthma requiring SABA rescue medication

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    End point title
    		 Proportion of days with nocturnal awakenings due to asthma requiring SABA rescue medication
    End point description
    The days with nocturnal awakenings due to asthma requiring SABA rescue medication were entered in an eDiary by the subject/caregiver in a 2-week period every 4 months, for up to 24-30 months. The proportion of days with nocturnal awakenings due to asthma requiring SABA was presented on a range from 0 to 1 (1 indicating that all days in the eDiary period were with nocturnal awakenings due to asthma requiring SABA rescue medication)
    End point type
    Secondary
    End point timeframe
    The efficacy assessment period for the endpoint started 4 months after treatment initiation and lasted until the end of trial or discontinuation of treatment.
    End point values
    		 Placebo 12 SQ-HDM
    Number of subjects analysed
    259 [3]
    253 [4]
    Units: Proportion of days
        number (not applicable)
    0.0190
    0.0147
    Notes
    [3] - Subjects from the full analysis set with observations in the efficacy assessment period
    [4] - Subjects from the full analysis set with observations in the efficacy assessment period
    Statistical analysis title
    		 Analysis of key secondary endpoint
    Statistical analysis description
    A marginal logistic regression model with a generalised estimating approach was analysed using treatment, visit, treatment*visit, age group (<12 years, >=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.
    Comparison groups
    Placebo v 12 SQ-HDM
    Number of subjects included in analysis
    512
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4156
    Method
    		 Marginal logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.7713
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.44

    Secondary: Proportions of days with SABA use

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    End point title
    		 Proportions of days with SABA use
    End point description
    The days with SABA use were entered in an eDiary by the subject/caregiver in a 2-week period every 4 months, for up to 24-30 months. The proportion of days with SABA use was presented on a range from 0 to 1 (1 indicating that all days in the eDiary period were with SABA use)
    End point type
    Secondary
    End point timeframe
    The efficacy assessment period for the endpoint started 4 months after treatment initiation and lasted until the end of trial or discontinuation of treatment.
    End point values
    		 Placebo 12 SQ-HDM
    Number of subjects analysed
    259 [5]
    253 [6]
    Units: Proportion of days
        number (not applicable)
    0.1094
    0.0943
    Notes
    [5] - Subjects from the full analysis set with observations in the efficacy assessment period
    [6] - Subjects from the full analysis set with observations in the efficacy assessment period
    Statistical analysis title
    		 Analysis of key secondary endpoint
    Statistical analysis description
    A marginal logistic regression model with a generalised estimating approach was analysed using treatment, visit, treatment*visit, age group (<12 years, >=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit is included as a covariate. No missing data approach was applied.
    Comparison groups
    Placebo v 12 SQ-HDM
    Number of subjects included in analysis
    512
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4146
    Method
    		 Marginal logistic regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8477
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.26

    Secondary: Percentage predicted FEV1

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    End point title
    		 Percentage predicted FEV1
    End point description
    Percentage predicted FEV1 was collected for efficacy assessment at on-site visits every 4 months, for up to 24-30 months.
    End point type
    Secondary
    End point timeframe
    The efficacy assessment period for the endpoint started 4 months after treatment initiation and lasted until the end of trial or discontinuation of treatment.
    End point values
    		 Placebo 12 SQ-HDM
    Number of subjects analysed
    259 [7]
    254 [8]
    Units: Percentage predicted
        number (not applicable)
    97.05
    97.17
    Notes
    [7] - Subjects from the full analysis set with observations in the efficacy assessment period
    [8] - Subjects from the full analysis set with observations in the efficacy assessment period
    Statistical analysis title
    		 Analysis of key secondary endpoint
    Statistical analysis description
    A 'mixed-effect model repeated measurement' model was analysed using treatment, visit, treatment*visit, age group (<12 years, >=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.
    Comparison groups
    Placebo v 12 SQ-HDM
    Number of subjects included in analysis
    513
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8829
    Method
    		 mixed-effect model repeated measurement
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.47
         upper limit
    		 1.7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from consent to last follow-up phone contact. Only treatment-emergent AEs are presented (AEs with start time on or after the time of first IMP administration and no later than 7 days after the last day of IMP administration).
    Adverse event reporting additional description
    For the first 28 days of treatment, an eDiary was used daily to capture presence/absence of 15 specific symptoms, identified as local side effects of sublingual immunotherapy (solicited events). These events were reported in the eCRF at the discretion of the investigator and are included in TEAEs presented. >5% non-serious events are in 12 SQ-HDM.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    12 SQ-HDM
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo 12 SQ-HDM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 263 (4.56%)
    14 / 270 (5.19%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Skin wound
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Eosinophilic oesophagitis
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic disorder
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 270 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular cyst
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 270 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    4 / 263 (1.52%)
    4 / 270 (1.48%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis allergic
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anorexia nervosa
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 270 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 270 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Growth retardation
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    2 / 263 (0.76%)
    0 / 270 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 270 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 270 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 270 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 270 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 12 SQ-HDM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    228 / 263 (86.69%)
    248 / 270 (91.85%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    44 / 263 (16.73%)
    54 / 270 (20.00%)
         occurrences all number
    68
    120
    Headache
         subjects affected / exposed
    11 / 263 (4.18%)
    16 / 270 (5.93%)
         occurrences all number
    13
    17
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    60 / 263 (22.81%)
    104 / 270 (38.52%)
         occurrences all number
    124
    257
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    12 / 263 (4.56%)
    14 / 270 (5.19%)
         occurrences all number
    13
    19
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    101 / 263 (38.40%)
    118 / 270 (43.70%)
         occurrences all number
    194
    231
    Aphthous ulcer
         subjects affected / exposed
    17 / 263 (6.46%)
    16 / 270 (5.93%)
         occurrences all number
    28
    28
    Diarrhoea
         subjects affected / exposed
    51 / 263 (19.39%)
    60 / 270 (22.22%)
         occurrences all number
    77
    96
    Glossodynia
         subjects affected / exposed
    18 / 263 (6.84%)
    74 / 270 (27.41%)
         occurrences all number
    23
    134
    Lip swelling
         subjects affected / exposed
    14 / 263 (5.32%)
    71 / 270 (26.30%)
         occurrences all number
    18
    154
    Mouth swelling
         subjects affected / exposed
    11 / 263 (4.18%)
    67 / 270 (24.81%)
         occurrences all number
    16
    159
    Mouth ulceration
         subjects affected / exposed
    16 / 263 (6.08%)
    26 / 270 (9.63%)
         occurrences all number
    17
    44
    Nausea
         subjects affected / exposed
    57 / 263 (21.67%)
    85 / 270 (31.48%)
         occurrences all number
    96
    167
    Oral pruritus
         subjects affected / exposed
    65 / 263 (24.71%)
    175 / 270 (64.81%)
         occurrences all number
    126
    475
    Swollen tongue
         subjects affected / exposed
    8 / 263 (3.04%)
    55 / 270 (20.37%)
         occurrences all number
    8
    98
    Tongue ulceration
         subjects affected / exposed
    9 / 263 (3.42%)
    19 / 270 (7.04%)
         occurrences all number
    15
    34
    Vomiting
         subjects affected / exposed
    14 / 263 (5.32%)
    33 / 270 (12.22%)
         occurrences all number
    19
    49
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    96 / 263 (36.50%)
    80 / 270 (29.63%)
         occurrences all number
    176
    158
    Cough
         subjects affected / exposed
    20 / 263 (7.60%)
    15 / 270 (5.56%)
         occurrences all number
    24
    19
    Pharyngeal oedema
         subjects affected / exposed
    14 / 263 (5.32%)
    58 / 270 (21.48%)
         occurrences all number
    23
    113
    Rhinitis allergic
         subjects affected / exposed
    23 / 263 (8.75%)
    16 / 270 (5.93%)
         occurrences all number
    47
    27
    Throat irritation
         subjects affected / exposed
    94 / 263 (35.74%)
    166 / 270 (61.48%)
         occurrences all number
    178
    494
    Infections and infestations
    Coronavirus infection
         subjects affected / exposed
    14 / 263 (5.32%)
    18 / 270 (6.67%)
         occurrences all number
    14
    18
    Nasopharyngitis
         subjects affected / exposed
    57 / 263 (21.67%)
    63 / 270 (23.33%)
         occurrences all number
    95
    110
    Pharyngitis
         subjects affected / exposed
    15 / 263 (5.70%)
    21 / 270 (7.78%)
         occurrences all number
    21
    28
    Upper respiratory tract infection
         subjects affected / exposed
    25 / 263 (9.51%)
    26 / 270 (9.63%)
         occurrences all number
    31
    38
    Viral infection
         subjects affected / exposed
    18 / 263 (6.84%)
    18 / 270 (6.67%)
         occurrences all number
    22
    18

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Nov 2020
    The trial started before the COVID-19 pandemic and ended during the pandemic. At the outbreak of the COVID-19 pandemic, measures to protect the safety and integrity of trial subjects were implemented in March and April 2020. The COVID-19 pandemic measures were implemented in a protocol amendment dated 11-Nov-2020 and included the main pandemic-related changes: - Screening and randomisation was paused as of 20-March-2020. At this point the last planned cohort was in the screening and randomisation phase - Site-to-patient shipment of IMP and rescue medication was introduced to enable subjects to receive IMP without going to site - Option to convert on-site visits to remote visits via telephone or video was introduced - Option to perform remote monitoring visits over telephone was introduced

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    20 Mar 2020
    Due to the out-break of the COVID-19 pandemic all screening and randomisation activities were stopped as of 20-March-2020. All subjects in the screening phase were screen failed. During the COVID-19 pandemic the asthma exacerbation rate decreased both in the trial population (blinded data) and in the general asthma population. This was likely due to the widespread adoption of virus containment measures, reducing the circulation of seasonal respiratory viruses, which are known triggers for asthma exacerbations. It was therefore deemed difficult to recruit further subjects based on a history of recent asthma exacerbations and recruitment of subjects was not restarted before the sponsor decided to end the trial with the completed subjects on 10-Aug-2022 due to the severe impact of COVID-19.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The trial was severely impacted by the COVID-19 pandemic, with a rate of clinically relevant asthma exacerbations declining from the period before to the period during the COVID-19 pandemic. Therefore the sponsor decided to end the trial 10-Aug-2022
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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